The Project Director (PD) is responsible for the overall coordination and management of clinical trials from start up through close out activities according to contractual time, quality/ cost parameters. The PD leads cross-functional teams and works with major functional area leads to identify/mitigate/escalate project issues and ensures solutions are implemented. Moreover, the PD is accountable for ensuring that all project deliverables meet the client/contract expectations, adhering to company standards/processes while ensuring overall client satisfaction.
Specific tasks would include:
- Primary interface with Client representatives as well as staff members in functional departments to ensure the timely initiation and completion of clinical trials.
- Assigned to manage a full range of projects; with preference given to complex, multi-service (e.g., Clinical, Data Management, Biostatistics etc.) to full service, large scale programs.
- Attend and present at client bid defense meetings.
- Prepares proposals, budgets and addendums.
- Represents Project Management on company-wide project teams.
- Interacts with clients and company vendors to ensure that all contractual obligations are met.
- Identifies potential bottlenecks and/or delays; develops and executes contingency plans in order to keep the project on schedule.
- Ensures adequate resource requirements.
- Coordinates initial client meeting identifying project objectives.
- Develops Project Management Plan to include timeline and milestones.
- Coordinates Project Team Meetings, including development of meeting agendas and minutes.
- Coordinates study specific training and other requirements for internal and external staff, as appropriate.
- Conducts daily, on-going communication via telephone and email, responding to inquiries and client requests. Interacts with clients and vendors to ensure that all contractual obligations are met.
- Interacts with company departments relating to project finances and information technology through the use and development of specific tracking and invoicing procedures.
- Manages budget throughout the duration of the project and develops out of scope documentation and costs.
- Manages the project trial master files.
- May participate with company senior management in marketing and business development activities including professional meetings, trade shows, seminars and client capabilities meetings.
- Contributes and participates in the analysis of departmental resource requirements.
- Identifies and assists in departmental training requirements including internal and external operations and project manager mentor programs.
- Contributes to the development and revision of Standard Operating Procedures (SOPs) and departmental policies.
- May participate in the analysis and development of Project Management Department budgets.
- Bachelor / Master degree, in a related field of study and a minimum of 10 years applicable industry experience or equivalent combination of education and experience.
- At least 6 years of experience as a clinical PM is required (CRO experience preferred).
- A very good understanding of project management techniques.
- Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
- Very good proficiency in Microsoft Word, Excel, and PowerPoint, Outlook and Internet Explorer
- Effective verbal and writing skills; English + local language, if relevant.